Cartherics opens clinical manufacturing cleanrooms in Notting Hill

Cleanrooms for clinical batches

Cartherics has opened cleanrooms in Notting Hill, Victoria, for clinical-scale cell therapy manufacturing. Ed Husic, Federal Member for Chifley, opened the facility at an event with stakeholders and industry partners.

Once validated, the facility is intended to manufacture clinical batches of CTH-401. The candidate’s initial indication is relapsed and refractory ovarian cancer.

Cartherics anticipates submitting an investigational new drug application to the US Food and Drug Administration in mid-2026.

The Ferntree Place facility includes:

• environmental monitoring of particles, airflow, pressure, humidity and temperature;
• closed processing systems and bioreactors;
• cleanroom-grade incubators and a bioburden testing facility.

Earlier private financing

Cartherics raised more than its A$15 million target in an oversubscribed private financing round announced on October 1, 2024. Existing investors and new private investors participated in the round.

The company earmarked that funding for initiating a clinical trial of CTH-401 in ovarian cancer and expanding its pipeline to additional disease indications. At that financing stage, Cartherics planned its first trial for 2025, following work in tissue culture and animal models. Those were preclinical studies.

The preceding research facility

Cartherics opened an A$4 million research and development facility in the same Notting Hill precinct on October 13, 2022. That investment covered laboratories, cleanrooms and biobanking facilities.

The 18,600-square-foot facility included offices, 580 square metres of certified PC2 and cell culture laboratories, and 156 square metres of cleanroom laboratories. These dimensions describe the 2022 development. Its equipment included cell-analysis instruments and dedicated low-temperature storage rooms.

Research and manufacturing development

The earlier facility was intended to accommodate more than 45 management, scientific and support staff. Cartherics planned to develop prototype manufacturing processes there for contract manufacturing organisations to produce material for local clinical trials.

The site is adjacent to Monash University’s main campus. Cartherics also planned to sublease part of its space to other companies developing their own technologies, bringing early-stage businesses into proximity with academic and government partners.